WHO Tool C Revised For Safety Injection Practices

Transcription

1 REVISED INJECTION SAFETY ASSESSMENT TOOL (TOOL C REVISED) W O R L D H E A L T H O R G A N I Z A T I O N

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3 WHO/EHT/08.08 REVISED INJECTION SAFETY ASSESSMENT TOOL (TOOL C REVISED) Tool for the Assessment of Injection Safety and the Safety of Phlebotomy, Lancet Procedures, Intravenous Injections and Infusions World Health Organization

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5 Tool C Revised Tool for the Assessment of Injection Safety and the Safety of Phlebotomy, Lancet Procedures, Intravenous Injections and Infusions Contents Abbreviations... 2 Introduction... 3 Definitions: Safe Injection, Phlebotomy, Lancet Procedure or Intravenous Device Insertion... 5 Procedures That Can Be Assessed Using Tool C Revised... 6 Requirements of an injection safety assessment tool Objectives of an Assessment Study design Sampling procedure Human subjects Data collection procedure Organization of the fieldwork Data entry and analysis Reporting Table 5a: Assessment items reflecting risks to patients Table 5b: Indicators reflecting risk to the provider Table 5c: Indicators reflecting risk to the community References Annex 1: Proposed schedule for an assessment of 160 facilities Annex 2: Data Collection Instrument Annex 3: Installing and using Epi Info TM Annex 4: Data entry and analysis using Epi Info TM Annex 4: Monitoring and Evaluation of Practices by a Supervisor.

6 Abbreviations AD BASICS II CHG DAP EPI HCP HIV/AIDS IMCI IRB MEASURE OPD RPF SIGN TST UNAIDS auto-disable (syringes) Basic Support for Institutionalizing Child Survival II Chlorhexidine gluconate Drug Action Programme (WHO) Expanded Programme on Immunization (WHO) health care provider human immunodeficiency virus/acquired immunodeficiency syndrome integrated management of childhood illness Institutional Review Board monitoring and evaluation to assess and use results Out-patient department Re-use Prevention Features Safe Injection Global Network time, steam and temperature Joint United Nations Programme on HIV/AIDS WHO / Essential Health Technologies 2

7 Introduction Tool C for the assessment of the safety of injections was first implemented in 2000, and has been used in over 90 national injection safety assessments since then. Owing in part to the use of Tool C, awareness about the importance of injection safety has improved in many countries, and an increased awareness of the importance of safety for other invasive procedures in health services has been stimulated. To respond to that need, WHO reviewed the lessons learned during field implementation of Tool C and applied those when designing an updated tool (Tool C Revised), a tool for the assessment of unsafe practices associated with injections, phlebotomies, lancet procedures and intravenous procedures. The safety of injections, phlebotomies, lancet procedures and intravenous procedures should be assessed using standardized, representative, simple and flexible methods that allow for a reliable assessment of the country situation and for comparisons with other countries. Additionally, if an assessment is done before the introduction of interventions to improve procedure safety, repetition of an assessment can measure safety achievements over time. Tool C Revised proposes a standardized methodology including concepts, study designs, sampling procedures, data collection methods and templates, and a plan for analysis and reporting for country safety assessments. An assessment using Tool C Revised can estimate the risk of infections associated with unsafe practices for each procedure type, determining whether a facility meets requirements for equipment, supplies and waste disposal, identifying unsafe practices and estimating the proportion of health care facilities in which practices are safely or unsafely performed. To incorporate an ability to assess the safety of procedures in the private sector, the sampling strategy has been adjusted to include sampling of service sites located in the same geographic areas as the public facilities randomly sampled from government facility lists. The ability to focus an assessment on a particular type of service, facility or procedure enables an assessment to target areas of concern within a health system; however, Tool C Revised can be used in a comprehensive assessment of the most common invasive procedures used throughout healthcare services in both the public and private sectors. Training materials included in the package permit standardization of data collection, which remains both observational and interview-based. Data entry, analysis and reporting templates are also provided to facilitate the process of developing raw data into a report that can transfer knowledge to health care providers, system administrators and policy decision makers. Recommendations following from an assessment can focus on three major considerations that are especially relevant in the assessment of practices: 1) the safety of the procedure recipient; 2) the safety of the health care worker; and, 3) the safety of the community. Although the main purpose for this assessment tool is to assess procedure safety at a national level, it also may be used at other levels. If a country is large and has many health facilities, assessments can be performed at a sub-national level (province or state) without changes in the sampling strategy. An abbreviated version of the questionnaire that is included can be used for supervision of practices at a district level or within a facility, or even for self-assessment by providers. Tool C Revised is designed to target public and private facilities providing primary care, including first and second level hospitals. It is not designed for assessment of tertiary care WHO / Essential Health Technologies 3

8 hospitals, such as university hospitals and specialty hospitals. The out-patient departments (OPD) of larger hospitals may also be appropriate sites to evaluate in an assessment if they have an administration and equipment supply (for the procedures evaluated in this assessment) that are separate from other units of the hospital. To enable countries to conduct assessments efficiently, Tool C Revised is also designed so that most countries will be able to implement the methodology without external assistance and with a minimum of time and resources. That efficiency and its adaptability make Tool C Revised suitable for assessment of the safety of injections, phlebotomies, lancet procedures and intravenous procedures in a wide variety of contexts using methods that are standardized, representative and reliable. WHO / Essential Health Technologies 4

9 Definitions: Safe Injection, Phlebotomy, Lancet Procedure or Intravenous Device Insertion There are three levels of definitions for a safe procedure. The first level is an ideal reference definition which is similar to that stated for a safe injection in the original Tool C Tool for the assessment of injection safety ( WHO 2001). The second level represents international best practices, which are a translation of the reference definition into an explicit list of critical steps on the basis of (a) best available evidence, or (b) expert consensus in the absence of evidence. The third level is the adaptation of international best practices into a national standard that takes into account operational constraints in the field. 1. Reference definition for a safe injection, phlebotomy, lancet procedure or intravenous device insertion A safe injection, phlebotomy, lancet procedure or intravenous device insertion does not harm the recipient, does not expose the provider to any avoidable risk and does not result in any waste that is dangerous for other people. This reference definition is ideal, but it cannot be used as a checklist of practices for assessment or evaluation. 2. Best practices for the safety of injections, phlebotomy, lancet procedures and intravenous device insertions The reference definition can be translated into a list of critical steps for which best practices should be followed. For example: i. In order not to harm the patient, each procedure should be administered with a new sterile single-use device, using the right medication, vaccine or fluid for infusion. ii. In order not to expose the provider to any avoidable risk, in general any needles used during a procedure should be placed in a puncture-proof closed container immediately after use without recapping. (Among the procedures considered within this assessment tool, the only exception to this rule is when a used two-ended phlebotomy needle is recapped using one hand prior to unscrewing it from an adapter.) In addition, providers of these procedures should be fully vaccinated against Hepatitis B. iii. In order that any waste produced during performance of a procedure does not become a hazard for other people, used sharps waste and infectious non-sharps waste should be safely managed and the final disposal of sharps containers and other medical waste should be conducted according to local and international health and environmental standards. The international best injection practices document is available on the WHO web site at ( 3. National standards At country level, international best practices should be adapted into national standards. These should be developed through a participatory approach that involves all stakeholders (e.g. those who administer procedures, those who order or prescribe them, those who are in charge of the logistics, etc.). Guidelines to develop country-level standards have been proposed (2). WHO / Essential Health Technologies 5

10 Procedures That Can Be Assessed Using Tool C Revised Tool C Revised is designed to assess the safety of the most common procedures within health services that puncture the skin including injections of various types, phlebotomy, lancet procedures and common intravenous procedures such as infusions. It is important to note that some people reserve the word injection for a procedure in which a medication, vaccine or other solution is deposited into to a patient, while other people use the word injection in a more general sense that includes needle insertions either to deposit these types of fluids into a patient or withdraw blood or other bodily fluids. Procedure types: 1. Intradermal, subcutaneous and intramuscular needle injections; 2. Dental injections; 3. Phlebotomies; 4. Lancet procedures; and, 5. Intravenous infusions and injections The most common procedure type is the injection that is intradermal, subcutaneous or intramuscular. These together with lancet procedures do not access the intravascular compartment, and therefore do not require patient skin preparation unless the skin at the intended insertion site is visibly dirty. They do not require that the provider use gloves unless it is likely that the provider will be exposed to blood or bodily fluids due to active bleeding or exudation. Phlebotomy and other intravenous procedures including injections and infusions require skin preparation at the intended puncture site with 2% chlorhexidine, tincture of iodine, an iodophor, or 70% alcohol, with drying of the skin after skin preparation and prior to performing the procedure also being required. A new pair of single-use disposable gloves is also required for all of these intravenous procedures. These measures also are required if any of these procedure types are performed on an existing intravenous system instead of directly into a vein, and in which case they should only be performed at injection ports. All of these procedures may commonly occur in outpatient departments (OPD) of various types. Injections occur in Expanded Programme on Immunization (EPI) and OPD services, phlebotomies and lancet procedures occur in laboratories and blood transfusion services, and intravenous infusions and injections may occur in both first and second-level hospitals. The settings in which each of these procedures occurs may vary by country. Best practices for intradermal, subcutaneous and intramuscular needle injections, phlebotomy and intravenous procedures are itemized below. If a country-level standard exists that is different than what is described here, certain items in the questionnaire may be deleted or modified and other items can be included if necessary. WHO / Essential Health Technologies 6

11 Best Infection Control Practices for injections, phlebotomy, lancet procedures and intravenous injections or infusions 1. Use sterile devices: i. Use a new sterile single-use device for each procedure. ii. Use a new sterile single-use syringe and needle to reconstitute each unit of medication or vaccine. iii. Inspect packaging of devices for breaches in barrier integrity. Discard any device if the package has been punctured, torn, or damaged by exposure to moisture or if the manufacturer s expiration date has already passed. iv. Maintain an adequate supply of single-use devices to enable providers to use new devices each time they perform a procedure. 2. Prevent contamination of devices, medication and fluids for infusion: i. Prepare procedures in a clean, dedicated table or tray where contamination of the equipment with blood, body fluids or dirty swabs is unlikely. ii. Never leave a needle in place in the stopper of the vial. iii. Use single-dose vials rather than multi-dose vials whenever possible. iv. If multi-dose vials must be used, always pierce the septum with a sterile needle. v. Select pop-open ampoules rather than ampoules that require use of a metal file to open whenever possible. vi. In all cases, protect fingers with a clean barrier (e.g., small gauze pad) when opening the ampoule. vii. Inspect for and discard medications and fluids for infusion with visible contamination (e.g., cloudy) or breaches of integrity (e.g., cracks, leaks) or which are expired. viii. Follow product-specific recommendations for use, storage (including maintenance of the cold chain where needed), and handling. ix. Discard a needle that has touched any non-sterile surface. x. Ensure that reusable phlebotomy holder-adapters used for performing phlebotomies are clean. 3. Prevent needlestick and other used sharps injuries to the provider: i. Anticipate and take measures to prevent sudden patient movement during and after performing a procedure. ii. Avoid recapping and other hand manipulations of needles. If recapping is necessary (e.g., if performing a procedure in a situation in which sudden patient movement is possible and not totally preventable), use a single-handed scoop technique for recapping. iii. Collect used sharps at the point of use in a sharps container that is puncture and leakproof and that can be sealed-shut when ¾ full. iv. Maintain an adequate supply of sharps containers that are puncture and leak-proof to enable providers to always have a sharps container available when they perform a procedure. 4. Prevent access to used devices: i. Seal sharps containers and containers for infectious non-sharps waste for transport to a secure area in preparation for disposal. After closing and sealing these containers, do not open, empty, reuse, or sell them. WHO / Essential Health Technologies 7

12 ii. Manage sharps waste and infectious non-sharps waste in an efficient, safe, and environmentally friendly way to protect people from voluntary and accidental exposure to used devices including ensuring that there are no loose, used devices anywhere inside or outside the facility or in open or overflowing sharps containers or infectious nonsharps waste containers. Other practice issues 1. Engineered technology: Whenever possible, use devices with safety features that are activated either automatically or manually which are designed to prevent reuse and needlestick injuries and which have been shown to be effective in protecting patients and providers. Auto-disable (AD) syringes prevent reuse of injection equipment, and should be the only type of injection equipment used in immunization services. All partners of immunization services should finance not only the procurement of the vaccines themselves, but also the safe administration of vaccines, provision of AD syringes, and safe management of waste. Partners should do this by planning and implementing immunization services in this way, as well as by supporting related training, logistics, supervision and sensitization activities (WHO-UNICEF-UNFPA joint statement on the use of AD syringes in immunization services 1999). 2. Provider's hand hygiene and skin integrity: Perform hand hygiene (i.e., wash or disinfect hands) prior to preparing injection material and giving injections. The need for hand hygiene between injections will vary based on whether there was contact with soil, blood or body fluids. Avoid giving injections if skin integrity is compromised by local infection or other skin condition (e.g., weeping dermatitis, skin lesions or cuts). Cover any small cuts on health care provider's hands. 3. Gloves: Gloves are not needed for intramuscular, subcutaneous and intradermal injections. Single-use gloves may be indicated if excessive bleeding is anticipated or when performing intravenous device insertions, infusions or phlebotomies. 4. Swabbing of vial tops or ampoules: Swabbing of vial tops or ampoules with an antiseptic or disinfectant is unnecessary. If swabbing with an antiseptic is selected for use, use a clean, singleuse swab and maintain product-specific recommended contact time. Do not use cotton balls stored wet in a multi-use container, and do not use an antiseptic where preparing a vaccination with a live attenuated virus. 5. Skin preparation prior to intramuscular, subcutaneous, and intradermal injections and lancet procedures: Wash skin that is visibly soiled or dirty. Swabbing of the clean skin prior to giving an injection is unnecessary. If swabbing with an antiseptic is selected for use, use a clean, single-use swab and maintain product-specific recommended contact time. Do not use cotton balls stored wet in a multi-use container, and do not use an antiseptic where preparing a vaccination with a live attenuated virus. 6. Skin preparation prior to intravenous device insertions, including phlebotomy, intravenous injections, infusions, and intravenous catheter insertions: Cleanse skin at the intended puncture site and injection ports with 2% chlorhexidine, tincture of iodine, an iodophor, or 70% alcohol, and allow drying prior to performing the procedure. 7. Insertion of needles into existing intravenous systems: Only use injection ports as a site for entry into the intravenous system. Cleanse the injection ports with 2% chlorhexidine, tincture of WHO / Essential Health Technologies 8

13 iodine, an iodophor, or 70% alcohol, and allow drying prior to administering an infusion into an existing intravenous system. 8. Guidelines and reminders of best practices: Ensure that guidelines, job aids and reminders of these best practices are available to providers to facilitate and reinforce the safety of common invasive procedures. These could be found at the following WHO website: WHO / Essential Health Technologies 9

14 Requirements of an injection safety assessment tool Tool C Revised attempts to meet the following three requirements: 1. Simplicity The assessment tool is intended to be as simple to use as possible, so that an assessment can be conducted rapidly and with limited resources. This tool is fully structured for ease of use, from the assessment planning stage through to data analysis and reporting. It comes with training materials to standardize the administration of this tool. Although the tool includes a large number of data collection items (interview questions and observation items), it should be feasible to train fieldworkers already familiar with health care practices to collect this data. 2. Standardization The assessment tool includes a core set of items that constitutes a checklist based upon the critical steps that make each procedure safe. Response types are mostly restricted to categorical options in order to both standardize the assessment and simplify data management and analysis. 3. Flexibility The assessment tool is compatible with various circumstances, but is intended for implementation in the range of facilities in which these procedures are performed. If the facility sampling procedure is followed as described, assessments performed using the tool will be more representative of the primary health care sector than secondary and tertiary care facilities. In addition, the flexibility of the tool accommodates the following: 1) Need for an assessment of one or more procedure types. 2) Need for an assessment at country, district, facility, or health post level. 3) Need for an assessment of the public and private sectors. 4) Need for an assessment of different facility types e.g. all health facilities offering outpatient services including first and second level hospitals, laboratories, blood transfusion services, doctors offices, etc. 5) Need for an assessment of different services e.g. EPI, Maternity, STD, TB, HIV/AIDS, and other special services. 6) Need for an assessment with levels of accuracy and precision adequate for policy decision-making. 7) Need for an assessment that samples facilities and health care points-of-service with a probability proportionate to population size. 8) Need to adjust the comprehensiveness of an assessment to the availability of various human, material and financial resources. WHO / Essential Health Technologies 10

15 Objectives of an Assessment The objectives of an assessment of the safety of injections, phlebotomies, lancet procedures and intravenous injections and infusions are: 1) To determine whether facilities where procedures are performed meet necessary requirements for practices, equipment, supplies and waste disposal. 2) To determine whether the critical steps of performing procedures are executed according to recommended best practices. 3) To identify unsafe practices that may lead to infections and that should be targeted by interventions to improve procedure safety. 4) To estimate the proportion of health care facilities where procedures are safe. WHO / Essential Health Technologies 11

16 Study design 1. Type of study Tool C Revised is a cross-sectional, observational study. 2. Types of procedures Tool C Revised is designed to enable determination of the extent to which injections, phlebotomies, lancet procedures and intravenous injections and infusions are consistent with national safety standards. 3. Types of provider, facilities and services Various providers may perform each of the procedures, and these may include doctors, nurses and phlebotomists for most procedures, but technicians and others may perform lancet procedures. The facilities and services involved include various primary care settings, dispensaries and offices, first and second level hospitals, and services for EPI, maternity, STD, TB, HIV/AIDS, other special services. The health care services and procedures that can be included in an assessment include those found in Table 1. Table 1: Health care services included in assessments using Tool C Revised* Service Procedure/s OPD Services: 1. Injections intramuscular, subcutaneous and 1. Both curative and preventive intradermal 2. Broad range of categories, e.g. 2. Phlebotomy maternity, STD, TB, 3. Lancet procedures HIV/AIDS and other special 4. Intravenous infusions and injections services 1. Injections intramuscular, subcutaneous and EPI intradermal 1. Lancets Laboratories 2. Phlebotomy 1. Phlebotomy Blood transfusion services 2. Lancets *These lists may vary by country The country or agency should define which facilities, programs and activities will be evaluated, and use this as a guide to determine how sampling should be performed. For most countries, a representative assessment of the public health service should be conducted, including primary health care services and first and second level hospitals in the base sample, and selecting one tertiary hospital in each survey area. If desired there could be a focus on particular services or procedures within the assessment by restricting the sample to facilities providing a particular service and/or restricting observations to particular procedures. Because many countries do not have complete lists of private sector facilities and most countries will want an assessment of the safety of procedures in the public WHO / Essential Health Technologies 12

17 sector, it is recommended that private sector facilities be sampled separately from public facilities. Facilities and services for which the assessment tool is not designed include in-patient departments, haemodialysis services and other higher levels of care, so that the tool is not designed for examination of procedures specific to those services, including more complex procedures and longer durations of intravenous infusions. Tool C Revised is not specifically designed for all of the procedures in these settings; however, it may be used to assess any of the procedure types specifically listed in the questionnaire. An assessment using Tool C Revised may not be representative of the safety of other invasive procedures or in other health care settings. Additional tools will be developed in the future to evaluate infection control procedures for other skin piercing procedures. In order to evaluate the desired procedure types in the desired settings, it is important to plan ahead to make sure that the data collection teams will have a higher likelihood of observing a number of the desired procedures in each setting. The questionnaire is designed so that observations on one of each procedure can be recorded. To be able to assess practices of providers in certain facility types that may not be listed on government-maintained facility lists, especially in the private sector, the proposed sampling strategy accesses non-listed providers and facilities after a mapping exercise that will identify the locations of private facilities for those cases in which the government does not have an up-to-date listing. 4. Integration with facility surveys conducted for other purposes 4.1 Integrated management of childhood illness (IMCI) facility surveys Background In the context of the IMCI, health care facility surveys are conducted to assess the management of sick children The collection of information relevant to injection safety During the IMCI health care facility surveys, information is collected regarding issues that are relevant to the safety of injections, phlebotomies, lancet procedures and intravenous procedures. Such issues include: sources of clean water, availability of devices for the procedures targeted in this tool, presence of a functional sterilizer, and the presence of a refrigerator Potential for integrated surveys If IMCI health care facility surveys are planned, arrangements may be made to simultaneously conduct an injection safety assessment. 4.2 Facility Surveys by WHO/UNAIDS/MEASURE (Monitoring and Evaluation to Assess and Use Results) WHO / Essential Health Technologies 13

18 The WHO/UNAIDS/MEASURE project [kvr1]which defines standardized packages to evaluate HIV/AIDS prevention activities contains a facility assessment package with which the injection safety assessment tool may be integrated. WHO / Essential Health Technologies 14

19 Sampling procedure Sampling should be done at least one month before the planned date for the start of data collection to allow sufficient time to investigate the existence of the sample (some listed facilities may not be operational, and therefore will need to be replaced), plan travel schedules and obtain relevant administrative authorizations. 1. Principle The sampling unit will be the health care facility. To minimize travel within the country, a twostage, cluster-sampling method is proposed as the easiest method to obtain a representative sample of health care facilities (3). In such a cluster sampling, self-weighting is ensured through (1) choice of regions in which clusters are selected using probability proportional to population size, and (2) equal numbers of sampling units within each cluster. 1.1 First stage Division of the country into regions Using existing administrative divisions within the country, the country should be divided into more than eight subdivisions, (or other administrative areas, e.g. districts, provinces, states, etc.) that are (1) non-overlapping (i.e.: no village should be located in two regions), and (2) exhaustive (i.e.: all geographic areas of the country should be included). The level of subdivisions should be chosen so that (1) there are more than eight of them, and (2) each contains at least 10 health care facilities of the desired type or types. If necessary, the country s subdivisions may be combined to form larger subdivisions containing a sufficient number of health care facilities. Please check against old tool C for more relevant information te: If some regions of the country cannot be visited for any reason (e.g. civil unrest), they should be excluded at this stage from the list of regions to be sampled, and the fact that they were excluded should be mentioned in the survey report Selection of subdivisions with a probability proportional to population size From the whole country, eight geographic regions will be selected with a probability proportional to population size. For this selection, the following six steps should be followed: Step 1: Rank all country subdivisions in a table All subdivisions should be displayed in the first column of a table, in whatever order is most convenient (see example, Table 2). Step 2: Determine the population size for each subdivision The population size should be obtained for each subdivision and written in column 2, next to the subdivision name (e.g.: 900, 000 for Region 10, Table 2). Census data or the most up-to-date information available should be used. Step 3: Calculate the cumulative population size WHO / Essential Health Technologies 15

20 When listing each country subdivision with its population, the cumulative population should be calculated by adding each subdivision s population to the total for all previously listed subdivisions and written in column 3 next to the subdivision population. For Subdivision 1, the cumulative population size is the population of Subdivision 1. For Subdivision 2, the cumulative population size is the population of Subdivision 1 + population of Subdivision 2. For Subdivision n, the cumulative population size is the population of Subdivision 1 + population of Subdivision 2 + ( ) + population of Subdivision n. For example: 4,850,000 for Subdivision 10 (Table 2). For the last Subdivision, the cumulative population size is the population of Subdivision 1 + population of Subdivision 2 + ( ) + ( ) + population of the last Subdivision. The total should be equal to the country s population. Step 4: Calculate the sampling interval The sampling interval S should be calculated by dividing the country population by eight (the number of Subdivisions [or Clusters] to be selected). For example: If the total country population is 8,150,000, the sampling interval S would be 8,150,000/8 = 1,018,750 (Table 2). Step 5: Choose a random number between 1 and the sampling interval A number R should be selected at random between 1 and the sampling interval (country population divided by eight calculated in Step 4). A random number within this range can be selected by a number of methods, two of which are described here. Only one of these methods would need to be used. For the purposes of illustrating the use of these numbers, the examples provided below are presented with the result being same random number. This number is used later in Table 1 to illustrate the sampling of the country Subdivisions: 1. Choose a random number between zero and one using a random number table and multiply the result by the sampling interval: A random number table contains random digits (0 to 9) arranged in rows. In a true random number table, all digits appear with equal probability, and the probability of any digit is not affected by the digits that precede it. A starting point is selected by closing your eyes and pointing randomly on a page near its center to identify the first digit selected, and then moving either left or right, or up or down, to obtain the desired number of random digits. For example, the following is a section of a random number table, in which the highlighted digit (6) was the one selected by closing your eyes and pointing randomly near the center of the page: Use a random number table in this way to identify nine consecutive digits that will be used as the nine consecutive decimal places of a random number between 0 and 1. The result from our example would be WHO / Essential Health Technologies 16

21 Multiply the random number obtained by the sampling interval S (e.g x 1,018,750 = 624,546.3) and round this number to the nearest digit to get a random number between 1 and S (R = 624,546). 2. Choose 5 single digits from 5 randomly selected currency bills, and use them to form the five consecutive decimal places of a random number between 0 and 1; then, multiply this random number by the sampling interval S to obtain a random number between 1 and S : Most local currency bills have serial numbers that can be considered random numbers if selected digits are used, as in the following example. Choose 5 local (national) currency bills and label them 1 through 5. From the serial number on bill number 1, select the last digit on the right: this will be the digit in the first decimal place of the random number between 0 and 1. From the serial number on bill number 2, select the last digit on the right: this will be the digit in the second decimal place of the random number between 0 and 1. After you have done this five times using the 5 different currency bills, you will have selected 5 digits in a consecutive order (e.g. 6, 1, 3, 0, 5, 1 ). Use these digits consecutively to form your random number between 0 and 1 (e.g ). Multiply the random number by the sampling interval S (e.g x 1,018,750 = ) and round this number to the nearest digit to get a random number between 1 and S (R = 624,546). Step 6: Identify the clusters Column 4 of Table 2 should be used to identify the country Subdivisions that are selected. First cluster: The first Subdivision selected will be that for which the cumulative population size (Column 3) is greater than the random number R, while the random number R is greater than the cumulative population size of the preceding Subdivision. The random number R should then be marked in Column 4 opposite that Subdivision. For example: 624,546 is smaller than 850,000 (cumulative population size for Subdivision 3) but greater than 550,000 (cumulative population size for Subdivision 2), so Subdivision 3 is selected as containing the first cluster (Table 2). Second cluster: The second Subdivision selected will be that in which the cumulative population size (column 3) is greater than R + S, while R + S is greater than the cumulative population size of the preceding Subdivision. The number R + S should then be marked in the fourth column facing the region. For example: 624, ,018,750 = 1,643,296 is smaller than 2,700,000 (cumulative population size for Subdivision 6) but greater than 1,900,000 (cumulative population size for Subdivision 5), so Subdivision 5 is selected as containing the second cluster (Table 2). Following clusters: Proceeding in the same way eight times, the Subdivisions will be selected by adding the sampling interval S each time to the number in column 4, and by identifying the Subdivision for which the number of cumulative population size (column 3) is greater than the new number, while the new number is greater than the cumulative population size of the preceding Subdivision. In some cases, the new number may fall in the same Subdivision. If so, the Subdivision is selected twice, and 20 facilities (2 x 10) will be selected from this Subdivision. For example: Because of its large population, Subdivision 13 is selected twice in our example (Table 2). WHO / Essential Health Technologies 17

22 Table 2: Example of selection of Subdivisions with a probability proportional to population size Country Subdivision Subdivision Population Cumulative Population Random Number (R)** plus zero or more sampling intervals (S) * Subdivisions selected Number of Facilities to be selected Subdivision Subdivision Subdivision Random number (R) Subdivision Subdivision Subdivision R + Sampling interval (S) Subdivision Subdivision R + 2S Subdivision Subdivision Subdivision Subdivision R + 3S Subdivision Subdivision R + 4S Subdivision Subdivision Subdivision R + 5S Subdivision Subdivision 13 (Capital) Total country population R + 6S R + 7S Twenty facilities will be sampled in Region 13. Subdivision 13 Subdivision Total sample = 80 * In this example, the sampling interval S = 8,150,000 /8 = 1,018,250 ** In this example, the random number between 1 and 1,018,250 using a random number generator was 624,546.

23 1.2 Second stage 1 Since most countries will want an assessment of public health services, a list of all public facilities in each country Subdivision should be obtained that includes all facilities: primary health care facilities, first level hospitals, second level hospitals and tertiary care hospitals. The list should then be divided based on the level of care one group including primary heath care facilities and first and second level hospitals, and the other including tertiary hospitals (including university hospitals and specialty hospitals). For each of the eight Subdivision s areas selected in the first sampling stage, 10 health care facilities are to be selected. Tertiary care hospitals should be selected separately from the other facilities. The 80 facilities that make up the 8 public facility clusters would consist of 72 primary care or lower level hospitals and 8 tertiary hospitals. In addition, three additional facilities should be randomly selected in each region to allow for replacements, in case they are needed (See 1.3). If it is also desired to perform an assessment of private facilities, for most countries it is recommended that private facilities are sampled separately from public facilities. (If a country has a list of private facilities that is complete, private facilities could be included with public facilities in one list and one random sample of health facilities could be assessed; however, this approach would provide safety estimates of the overall health system and conclusions about either the public or the private system may not be appropriate.) Random sampling From the two lists of public facilities for each country Subdivision, 10 facilities are selected at random, 9 from the list of primary heath care facilities and first and second level hospitals, and one from the list of tertiary hospitals, each time selecting a random number between zero and one using one of the methods described above (Section 1.1.2, Step 5), and then multiplying the result by the number of facilities on the Subdivision list. 1.3 Third stage - Identification of additional facilities from the private health sector that are to be evaluated If a complete list of private facilities is available, sampling of private facilities could take place for each selected Subdivision as described for selection of public facilities in 1.2 above. If a complete list of private facilities is not available (which is often the case), the identification of non-listed facilities and services can occur by performing a mapping exercise in each selected country Subdivision before the assessment. A mapping exercise to identify private sector facilities and service points can be as thorough as the amount of time and resources devoted to it. To limit the time and resources required for mapping, the exercise could be limited to the selected Subdivisions in which the selected facilities are located. 1 The indicators and collection tool could be used also with different sampling strategies, but the one presented in Tool C Revised has been shown to be feasible and usually produces a representative result. WHO / Essential Health Technologies 19

24 2. Sample size The total sample size would be 160 facilities: 8 x 10 = 80 health care facilities selected directly from a current list of public facilities, and 8 x 10 = 80 private sector facilities selected from lists of private facilities in each country subdivision identified during the mapping exercise. 3. Replacements Care should be taken to visit all selected facilities in the base sample without replacement wherever possible. Replacement should be limited to facilities that are found to be not eligible once teams are in the field (e.g. facilities where the procedure/s of interest are never given, facilities that are closed or facilities only yet under construction). Replacement of facilities should occur by the following method: Each survey area should be over-sampled by three facilities of each sector assessed (that is, 13 facilities should be selected instead of 10 as explained in Section 1.2) before going to the field. Each team will carry a list of replacement facilities and their locations. If a team determines that a selected facility is ineligible, the team should replace it with the replacement facility that is closest in terms of driving distance or estimated travel time. A public facility can only be replaced with another public facility, and a private one can only be replaced with a private facility. Replacement of facilities simply because they are difficult to access should be avoided as this could lead to a bias through over-representation of easily accessible facilities that may receive better staffing, equipment and supplies. Hard-to-reach facilities should be identified at as early a stage as possible to plan for extra access efforts, special transport arrangements, etc., so that they are not omitted from the survey. In those cases where access is temporarily difficult due to factors that may change within days, the team should attempt access at least once more at a later date before resorting to choosing a replacement. WHO / Essential Health Technologies 20

25 Human subjects This tool is designed for the assessment of the safety of injections, phlebotomies, lancet procedures and intravenous procedures performed during routine healthcare delivery. However, before conducting this assessment, evaluators should check with the Ministry of Health and donor organizations that might be involved, if any, on the need for an ethics review by an Institutional Review Board (IRB). During the process of making observations for the assessment, surveyors should intervene to prevent potential harm if they are about to witness health care procedure practices that are of particular danger to a procedure recipient (e.g. re-use of equipment for an invasive procedure without sterilization). WHO / Essential Health Technologies 21

26 Data collection procedure In order to obtain accurate information, this tool proposes methods which obtain information using a combination of interviews and structured observations. Information to be collected includes: 1) Structured observations of facilities and worksites, including available supplies. 2) Structured observations of practices. 3) Reported availability of equipment and supplies, and 4) Occupational health issues. Collected information sometimes is to be used to determine other items in the assessment. For example, the fieldworkers must determine whether the number of equipment pieces available is at least twice the average number of procedures performed per week, as stated by the supervisor. A sample data collection instrument is provided in Annex 2. (The choice of two weeks is based on the assumption that most facilities receive deliveries of equipment once per month. The two-week limit can be adjusted based on the country's logistic cycle.) 1. Pilot testing of the data collection instrument in the country The proposed data collection instrument should be pilot-tested in each country to ensure that each data collection item is suitable for the particular circumstances and that the right nomenclature is used. The pilot test can be conducted in a limited number of health care facilities prior to training the fieldworkers. Following the pilot-test, minor adaptations to the data collection instrument may be relevant for specific items, for example according to the type of equipment used or other local circumstances. These changes should be kept to the minimum in order to maintain standardization. 2. Recruitment of the fieldworkers A sufficient number of fieldworkers should be identified so that the fieldwork can be completed within two weeks. For an assessment involving facility evaluations (80 in the base sample plus an additional 80 private facilities) it is estimated that eight teams, each with three fieldworkers and one driver, can complete the fieldwork in 10 days during which health facilities are operational (Table 4). It may be necessary to have an additional more experienced person supervise the data collection of each team. The supervisor would be responsible for the overall quality of the data, and for ensuring that the completed questionnaires are kept safe and delivered to the lead investigator in a timely manner. WHO / Essential Health Technologies 22

27 Table 4: Estimated parameters for fieldwork for an injection safety assessment of facilities* Calculations for 80 facilities Calculations for 160 facilities Survey time spent in each facility on average 5 hours 5 hours Number of facilities or service points visited by 1 Survey Team in 1 day 1-3 *** 1-3 *** Number of facilities or service points to visit for each Survey Team Number of working days needed for each Survey Team to complete one region (assuming a sample that contains one hospital and nine lower-level facilities per region) 10 (assuming 10 public facilities) 5 20 (assuming 10 public facilities and 10 private facilities) Number of survey regions to visit 8 8 Number of survey teams 4 4 Number of working days it will take to complete an assessment of health facilities**** *A sample of 80 base sample facilities and up to 160 additional facilities (or other service points) that are in the local areas of the base sample facilities and assessed on the same day. ** If there are less than five days per week for which health facilities are operational would usually make it necessary to allocate more days for the data collection period. *** 1 selected lower-level public or private facility can be completed per day by each data collector in the same local area. Each hospital typically requires one day with the entire team working together. **** The schedule for fieldwork should take into account two non-operational days per week for facilities for the weekend as well as any local holidays. The budget may still need to include per diem costs for the field workers, however, if they are not able to return to their homes for the weekend. 3. Training of the fieldworkers 3.1 Objective The purpose of the training of fieldworkers is to ensure that all fieldworkers will collect information appropriately using the same methodology. Because of the need for all data collectors to be approaching the data collection in the same way, the trainers should consider limiting the number of teams. Generally, the more fieldworkers that are hired for a survey, the more difficult it will be to standardize all of them to ensure good quality data. Four teams is suggested in Table 4 above. 3.2 Initial training Fieldworkers should be trained to collect data in an exhaustive and standardized way while remaining respectful of patients and the health care workers and their work. The purpose of the assessment and the importance of its sampling methodology should be explained. Some background material on injection safety should be presented that includes the proper performance of each procedure that is to be observed. (? Also available on the Internet at ). Samples of the various devices likely to be found in use within facilities in the country should be shown to the fieldworkers. The data collection instrument should then be reviewed with the fieldworkers line by line including all skips and instructions to ensure that all of the questions / survey items are understood and that fieldworkers clearly understand what is required of them. Field workers and supervisors should also be instructed to WHO / Essential Health Technologies 23